Document rp62y6e3wGMwxQpdrwVrp6XY0
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Memo
Due Rebmary26,2007
To:
Vi
From
Subject:
John Stine, Environmental Health Division Directorslo
LaryOus,Eos SvssudAssnESN on Masses Pi"
Panel hubs, Realh Kisk Assent Unit Supervisor, ot hy
HelenGooden,Healthisk Asset Uris?7.
IN
Health Based Values for Perfluorooctanc Sulfonate (PFOS)
CIa no2r0l0 hieoMwiositossoDamepoarrntameshneofHdHonedthheR(EMtDAHnodcesvreeilompeUdgntHsoBAfoPVfepcpSfmooxPMEnSt,nrSeiFeOSV20so02n
PFOS be lowered to 0.3 ug/L (ppb).
The following formation waswis in goaths ris FY:
SCohmeamlical ~~ COASS#L chyo Enddpoin nt od RID (mg/kg-d) HBVHBA)(ug/l) Sfoaunrsce coMereuergdcahwledsnbfahocromaotwoinhse ApFVrpe aonhdepdeerovyeolsiohpoamlnedndtbofonthne HdnBYo, irpoarttocochre..sPForlaftsesbsieoanpdtvieseiegotfnh, voembeonccomops leihisHnV. MOP wiroto i FV sn when sation vis T0heiMoDnEshtehs oStgorprriomoutlgiayoteheeaidty otietsSdaeryt.heGberthoDuedtvPreosts,tiwohniAcBtshted o`prmomdulgatied expaosuhre vawluees,sseervse iasHinteirimtadvmicoetissubed foer spewcifsic simteesSwhveerneea dconotramoienapntphees
of providing an upper limit for degradation.
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Exhibit
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2132.0001
ATTACHMENT (Corrected March 9, 2007) DATA FOR DERIVATION OF GROUND WATER HEALTH BASED VALUE (HBY) CChAeSm:ic1a7l6N3-a2m3e1: (Paecirdf)luorooctane Sulfonate (PFOS) 7209202851--1546--89 ((daimemtohannioulmamsianlet)salt) 2795-39-3 (potassium salt) 29457-72-5 (lithium sale)
Non-Cancer Health BasedValue (HBV) = 0.3 ug/L = (toxicity value, merkg/d) xi(nrtealkaetirvaete,soLuirkcge-dco)ntribution) x (1000 ugimg) (0.000075mg/kg/d) x (02) x (1000 ug/mg) (0.048 Lkgiday) - 03 ug,
Toxicity value
0000075 my/ke-d (Cynomolgus monkeys)
PSooiunrtcoeoffDetopxairctiutryevalue: MmiDniHma2l00L7OA(ERLI,D d0e.r1i5vemdg/bkyeM-dDH)
Dose Metric Adjustment: 21032(1d0ayasdjiunstCfyonrohmalofl-gliufse dmuornakteioyns)of 5.4 years in humansversus 110
TUoFuallluonccaetritoaninty factor: 310i0nterspecies tosicodynamic differences, 10 intraspecies variability;
aLnOdA3ELLOrAaEthLe-r1t0ha-nNuOsAiEngLt(haevNaOluAeEoLf3otwhaes adpepflaiueldt tUoFtohefs1t0udbyecause
tsehveeerfifteyc)t observed at the LOAEL was considered to beofminimal
Critical effect(s)*
Decreased HDL and T3
CAod-dcirtivtiictayleenfdfpeocitn(ts()s"): NHeopnaetic (iver) system, Thyroid (E)
Secondary effect(s)" Developmental (decreased body weightweight gain, decreased total
Cf eglmion T4), decofreased getsetmastion lengtsh,d immuneGslysstem alteratlioensd
pus heal se mn di elroundatleorssg im
Cancer Health RiskLimit (HRL) = N/A
Volatile: No
tachment Page | of7
2132.0002
STATE_01488042
`Summaryof changes since 2002 11BV: TIomxpircoivteydVtoaxliuceok(iRnIeDt)ic (.., half-ife) information allowed for the incorporation ofa 20-fold dose`tmheetrtiotcaladUjFu.stImnen2t00b2asaed30o-nfohladlff-alcitfoerdi(3ffienrteenrcsepsecbieetsweexetnrahpuolmaatnisoan n+d1m0osnukbechyrsoannicd-{ao-1c0h-rfoonlidc)dewcarseuassieden to address uncertainties around toxicokinetics. IPnFtOaSk,e ruantleike mos: ground water contaminants,has along half-life and therefore will accumulatien the bPoEdOySifwirlelpeeaatcehd eaxpploastucarue o(sstceaardsy-ostvaetre)l.ongT-hpeerlieondgstohfofimtei.meEtvoenrteuaaclhlsyctahceyinstteartnealcocnodnicteinotnrsatision of aeqpupirvoaxliemnattel0yap2p7royxeiamrast(e5lyx h$uhmalafn-lhiavels.lifIenotfhe c5a4syeeoafrs)P.FTOhSetihneatkiemerattoessteelaedcyt-esdtaftoer wthoeulrdevbiseed HBV wd)a. sTahitsiimnet-awkeeigrhatteedinacvoerrpaogreatienstatkheeofhigahnerupipnetra-keenrdatceosnesaurmlyerionvleifre (ti.he fiirnstfa2n7tsyanedcoahfirlldirseen0)a.0s4w8elLlikagsthe accumulationofthe chemical over ime. CGornoswitdherdeafticiiotns,ofalSteenrsiattiivoeinnsPotphuylraotiidohnso:rmone levels (T4 and T3), increasedliver weights, and delays oinbsdeervveeldopatmednotsehsaavpepbreoexnimraetpeolryte3dtion7oftfismpersinhgigehxeprotsheadndtuhreincgridtiecvaelsotpumdeyntm.iniTmhaelseLOefAfEeLct.s wPeorteential shceeanlatrhi-obsasweedrvealevueelsubataesde:d 1o)naprlootnegc-ttieornmofexapporseugnrae--ntexwpoomsuarne oandthheermoftehtuesrwferroemebviatluhatteoda.geTw27oyears, and 2) short-em exposure -- exposure 0 an infant. The long-tem exposure scenario incorporated asccecnuamruiloatdiidonnootveirnctoirmpeoraantde uatcicluizmeudlaattiiomneo-vweerigthitmeedbiunttadkiedautiel0z.e0a48yoLuikngg-di.nfaTnhteinsthaokret-rtateermofex0.p2o2s1ure Lkg-d_ The resulting potential HBV for both scenarios were not lower (i.c., more restrictive) than the HBV based on the selected critical study in monkeys.
Summary of toxicity testing for health effects identified in the Health Standards Statute: Tested? [EndoScercine [immunotVoessicity [DeveYloepsment [ReprodVuecstive TNeurotoVxeiscity |
Observations' a"NvoatielbElxeafrroTmHsEiSdEesocronsdpceciifdicforaolelrTpucrposweass. fMoorsCtochnedmiictalTsorhaivse bcTeeemnicsaubljectfotormmatiiloneabsoiu cofinTwehitchiy bc areoscearbchoerss donetfheyfaedtosaebwshrevraedmoa etfhfeecltoswwesetrdoosbeseacrrvoes.salnldahveailwbelsetstduodies hsatconsuisdeedreodneproortmeoirenoefailsotAhefloseitctsy hat occur at hisherdoses. C"Tohmymreoindtshoornmoenxatlenpterotfurtbeasttiionngsorhaevffeecbtese:n observed in laboratory animals a dose levels similar to the erSthiocratl-tsteurdmy iLmOmuAnEoLt.oicAilttyersattuidioeinsnshtahvyerosihdohwonrtmhoant ePleFvOeSlsehxapvoseurbeeeanltiedresnsteivfeireadlasimcmruitnioclalogeifcfe.ct parameters (suppressionof SRBC-specific [gM production and T-cll proliferation, increased natural Killer cell activity) at levels below the critical study LOAEL. The biological significance of these effects
tachment Page 2 of7
2132.0003
STATE_01488043
ihsunmoatnesntairse2lyrcleearo.sfaFluutretrhlaetriotsntsudiyn iisnmemeudneedfutnocdtieotne,rmhionweevwehre,thtehre PMFDOHS wpiolslesinpcoltuednetiialmmheuanlethsryisstksetmoas a*Lsoewcoenrdabroydyefwfeecitghatt tihnisoftfismper.ing, decreased T4, increased sternal defects and decreased gestation length hhaavvee bbeeeenn iredpeonritfeidedatatlesveeclosnadpaprryoxeiffmeacttse.lyAl3-dfoosledshaipgpherroxtihmaantetlhye c1ri0t-icfalldshtiugdhyerLOtAhaEnL.theTLheOsAeELef.fects a"dAditmiaonlael rdeepvreoldoupcmteivnetasltuefdfyecrtespo(rdteecdredaescerdepasuepsviianbislpiteyr,mdecvouenltopamnedntainlcdreealsaeyss)ianrespoebsremrvdeedf.ormities at l*eHvyeplosac10i-iovledrheisgphoenrsetshatno ntihceoctriinteichalasstbuedeynLoObsAeErvLed in neonatal mice acutely exposed tolevels 75-fold higher than the critical study LOAEL but these effects were not observed at levels S-fold higher e`Cxopnovsueldsi1o0nsl,evseelvsearpeprriogxidiimtaytaelnyd 3b0o-dfyoltdrehmibglhienrgthhaanvethbeeecrnitoicbaslersvtueddyinLORAhEesLu.s monkey'ssubchronically
Atachment Page 3 of7 2132.0004
STATE_01488044
`The following sources were reviewed in the preparation ofthe HBV: APenrdfelrusoernc,alMkEyl,aceitdsali,n 2M0o0n6kPehayr-smaPcrookbiinnegtitcheMoDedteelrimnignaonftSsatoufraLbolne,g RPelnaaslmaReHsaolrfp-tLiivoens.ofToxicology (online)doi:10.1016/tox 2006.08.04 ATu1s(t1i2n)e1t4al8,5-N1e4u8r9o,en2d0o0c3rine Effects of Perfluorooctane Sulfonaiten Rats. Eny Health Perspect Bondy G, I Curran,L Coady, C Armstrong, M Parenteau, V Liston,L Hierlihy,J Shenton. ITmoxmiucnoolomgoidstu,laAtbistornacbty#p1e0r1f,lu2o0r0o6o,ctanesulfonate (PFO) in a 28-day rat feeding study. The Butenhoff etal, Perfluorooctane Sulfonate-Induced Perinatal Morality in Rat Pups is Associated with a Steep Dose-Response. The Toxicologist 66(1): 25 (Abstract 120), 2002, (BPuFtOeS)n.hoTfehfte aTl,oxTihcoylroogiidsth,oArbmsotnraecstta#t1u7s4i0n,a2d0u0l5t,female rats after an oral doseofperfluoroctanesulfonate: Curran etal, Pefluorooctanesulfonate (PFOS) Toxicity in the Rat. A 28-Day Feeding Sudy. The Toxicologist Abstract #102, 2006 FfuannctYiOo,noJfinmYalHe,rMatas]Y[XA,rtZichlaenign YChHin2e0s0e5]. W[eiEShefonfgfpYearenflJuicouroJtoacnt3sa4n(e1s)u:l3f7o-n9ate(aocncesspseemdniatogenesis i1t5p86/2A0v1w8)ncbi nim nih gov/entrez/queryfegi?cmd=Retrieveddb=pubmeddopt=Abstractalist_uids= Food Standards Agency, Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment. Second Draft Working Paper on the Tolerable Daily Intake for Perfluorooctane Sulfonate (May 2006), Food Standards Agency (a United Kingdom Government Agency), Committee on ToxicityofChemicals in Food, Consumer Products and the Environment. Minutes of the July 11, 2006 meeting tFhoeoEdnvSitraonndmaerndts.AgeCnOcyT,SCtaotmemmietntteoenotnheToTxoilceirtaybl(eCODaTi)loyfICnthaekmeifcoarlPseirnflFuooordo,ocCtoannseuSmuelfroPnartoeducts and (November 2006). tFouxeinctoelsogSy.: McToncCuorlroemnitneax,pJosRuorderitgoupeezr,flPuoVriocoencst,anJesLulDfoomniantgeo,(PIFnOtSe)raacntdisoitnrnsesdseivneplroepgmneannttalmice. Toxicology Letters 164:81-59, 2006. ``wGaetremrawnitMhintihsetgruyiodfe HseuablstthanDcreisnpkeirnfglWucartoeorciCaonmomiicsasciiodn(.PPFrOoAv)isiaonndalpeervfalluuoartoioocntaonfePsFuTlfionnadtrei(nkPiFnOgS) adsrienxkaimnpgl-ewsa.teJrulpydf13,2006. hp://www.umweltbundesamtdejuba-info-presse- hintergrand/pf-in-
tachment Page 4 of7
2132.0005
STATE_01488045
G(rPaFsOtSy)etinalt,heCrRiatti.calThPeerTiooidcfoolroIgnicsrtea6s6(e1d):Ne2o5na(tAablstMroarcttal1i1t8y),In20d0u2c.ed by Perfluorooctane Sulfonate Grasty etal, Perfluorooctane Sulfonate (PFOS) Aliers Lung Development in the Neonatal Rat. The "Toxicologist, Abstract # 1916, 2004. `HmuemWbernanyeuep,roPpDe.rtiJeosnecsa,usWedDbeyCopeenrf,luLorKiinnagt,edPcFormapkouenrd,JsN.ewCsotmpeadraantdivJePGBiieocshyem2i00s3t.ryA<ePrhaytsiioonsloignycel Part C 135 77-85. `HguenWe eexnpryeuses,ioPnD.prJofoinleisn,g.TCeEnlviiursonamnedntJaPlGiTeoxsiyc2o0l0o5g.y aInddenPtihfaircmataicoonolfoggyenJeans(rVeoslpo1n9s,ivIesstuoeP1)F: O5S7-u70s.ing Johansson, N, et al. 2006. Neonatal exposure to perfluorooctanesulfonate (PFOS) and cpheorlfilnueorrgciocctsaynsctiecmacinidad(uPlFtOmAic)e.caTuhseesTdoexriaconlgoegdisbtehAabvsitoruarcta#nd1i4n5c8reased suscepibiltyof the Keil DE, T Mehlman, I. Butterworth, MM Peden-Adams Gestational exposure to PFOS suppresses immunological function in 1 mice. The Toxicologist Abstract #882, 2005. LPaous,tneattaall,Ev2a0l0u3a.tiEonxsp,osTuorxe tSociPe74r:fl3u8o2r-oo3c9t2ane Sulfonate during Pregnancy in Rat and Mouse. 11. Lau, etal, 2004. The developmental toxicity of perfluoroalkyl acids and thir derivatives. Tox Appl Pharm 198:231-241 ALbasutreatcalt,#2507066.. EvaluationofPerfluorooctane Sulfonate (PFOS) in Rat Brain. The Toxicologist Lieder PH, PE Noker, GS Gorman, SC Tanaka, JL Butenhoff. 2006. Elimination Pharmacokinetics ofa `SCeryineosmooflgPuesrlMuoonrkienaytse.d PAolsktyelrCparersbeonxtyaltaitoen aatndthSeu2lf0o0n6atEeusr(oCp4e.anC6SEanTdACC8)meientiMnagleinanDdenFeHmaagluee, Netherlands. LpeorgfalnuoMrcNo.ctJaRneTshuilbfoodnaetaeu,(PFROGS)Haonnsothny,roMidShtroyrnmaor,neAsLtiantdusstirnoma,dulCt aLanud. n2e0o0n4a.talEfrfaetcs.tsTohfe Toxicologist Abstract #1917 (LPueFbOkSe)r,inD.ratest.al.ToxTiwcoo-lgoegnyer2a1t5i1o2n6-r1ep4r8o,du2c0ti0o5n and cross-foster studiesofperfluorooctanesulfonate Luebker, D. etal, Neonatal mortality from in utero exposure to perfluorooctanesulfonate (PFOSi)n 2S1p5r:a1g4u9e--1D6a9w,l2e0y0r5at,s: Dose-response, and biochemical and pharmacokinetic parameters. Toxicology Karrman A, I Ericson, B van Bavel, PO Darnerud, M Aune, A Glynn, Lignell and G Lindstrom. 2006. aEnxdpoasTuermepoofrPaelrfTlrueonrdo,in1a9t9ed6 C-h2e0m0i4c,alisn Stwherdoeung.h LEaHctPatOinolni-neLeNvoevlesomfbeMrat20c0h6e.d Human Milk and Serum
tachment Page Sof 7
2132.0006
STATE_01488046
Maras, M et al, 2006. Estrogen-like propertiesoffluorotelomer alcohols as revealed by MCF-7 breast cancer cell proliferation. Env Hith Perspe 114(1)'100-105. Oplesrfelnueotrca,hex2a0n0e5suElvfaolnuaattei(onPoFfHSt)heahnadlp-eirffelu(o11r/o2o)cotfaneolaitmein(aPtFioOnA)offpreorfmlhucurmoaonctasenreusmu.lfFonLaUteO(RPOOSS), Intemational Symposium on Fluorinated Alky Organics in the Environment, TOXO17) oOfrPgearnfilzautoiroonocftoarnEecSounlofmoniacteCo(-PoFpeOrSa)tiaonndatnsdSaDletsv.elopment (OECD) Nov. 21, 2002. Hazard Assessment (iAtcpc/esAsvewdoNoove.cd2o0r0g2/)document/S8/0,2340,en 2649. 37465 2384378 111 37465.00 hum Peden-Adams, et al, Oral Exposure to PFOS for 28 Days Suppresses Immunological Function in BGC3FI Mice. The Toxicologist Abstract #573, 2006. MSeoanckaetyset.alT,oSuSbccih6ro8ni2c49T-o2x6i4c,it2y00S2tudies on Perfluorooctanesulfonate Potassium Salt in Cynomolgus TakacsML and BD Abbot. 2007. Activation ofMouse and Human Peroxisome Proliferator-Activated 9R5e(c1e)p,to1r0s8-(1a1,75. , ) by Perfluorooctancic Acid and Perfluorooctane SulfonateToicological Sciences Tanaka et al, 2005 Thyroid hormone satus in adult ras given oral dosesofperfluoroocianesulfonate. FLUOROS: International Symposium on Fluorinated Alky Organics in the Environment, TOXO18) TIanntraakvae,no,usetDaol.se20o0f612E5ffIe-cLtasboeflePderTfhlyuroorxcioncet.anTehseulTfoosniactoeloognis1t25A1bsEtlriamcitna#t5i7o3n in Rats aftar Single Thayer, K. 2002. Environmental Working Group: Perfluorinated chemicals: Justification for inclusion of hthiitspchevwmicalewclgasosrgin/rteheponrattiso/npaflerweoprorltd/opndhFuEmWGa_nCeDxCpopsdufre to environmental chemicals "Thiboceaus, et al, Exposure o Perfluorooctane Sulfonate during Pregnancy in Rat and Mouse. |. Maternal and Prenatal Evaluations Tox Sci 74: 369-381, 2003. "PTehrofmlfuoorrdo,ocPt.an2e00S2ulFfionnailc RAecpiodrt:Pot1a0s4sWieumeSkalDtie(tPaFrOySChrTo-n6i2c95T)oxiincRiattys.an(dAbCsatrrcaicntoognelnyi)city Study with G3-Mmo2n0t0h2.orPaelrsdoonsailngcosmtumduyniincamtoinoknefyrsodmeDvre.loJpoehdnbByutDern.hoGfafy.loNrov 25. 2002. Benchmark doses from the 3M 2003. Environmental and Health Assessment of Perfluorocctane Sulfonic Acid and is Salts. UK Environmental Agency 2004. Environmental Risk Evaluation Report Perfluorooctanesulphonate (PFOS)
Atachment Page 6 of7 2132.0007
STATE_01488047
U.S. EPA 2003. Toxicological ReviewofPerfluorooctane Sulfonate (PFOS) In SupportofSummary. Information on the Integrated Risk Information System (IRIS). September 2003. External Peer Review Draft
Attachment Page 7 of7 2132.0008
STATE_01488048